Ribomunyl

Informazioni principali

  • Nome commerciale:
  • Ribomunyl Granulat
  • Forma farmaceutica:
  • Granulat
  • Composizione:
  • frazioni ribosomales RNA 525 µg di klebsiella pneumoniae 14 % e streptococcus pneumoniae 12 % e streptococcus pyogenes 12 % e haemophilus influenzae inactivatum 2 % e klebsiella pneumoniae membrana 60 %, excipiens annuncio granulatum per 0,5 g.
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco allopatico

Documenti

  • per i professionisti:
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.


    Richiedi il foglio illustrativo per i professionisti.

Localizzazione

  • Disponibile in:
  • Ribomunyl Granulat
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Batteri e Hefepräparate
  • Area terapeutica:
  • Immunstimulans in caso di Infezioni ORL e Atemwegsbereich, di età 1. Anni

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 570
  • Data dell'autorizzazione:
  • 04-08-1994
  • Ultimo aggiornamento:
  • 07-09-2017

Foglio illustrativo: composizione, posologia, indicazioni, interazioni, gravidanza, allattamento, effetti indesiderati, controindicazioni

Patienteninformation

Diverse

Informazione destinata ai pazienti

Legga attentamente il foglietto illustrativo prima di far uso del medicamento.

Questo medicamento le è stato prescritto personalmente e quindi non deve essere consegnato ad altre

persone, anche se i sintomi sono gli stessi. Il medicamento potrebbe nuocere alla loro salute.

Conservi il foglietto illustrativo per poterlo rileggere all’occorrenza.

RIBOMUNYL®

Che cos’è Ribomunyl e quando si usa?

Ribomunyl è utilizzato per la prevenzione delle infezioni ricorrenti delle vie respiratorie superiori

(gola, naso e orecchie) nei bambini di età superiore ai 2 anni.

Ribomunyl è disponibile sotto forma di granulato (per i bambini dai 2 anni in su) e di compresse (per

i bambini dai 6 anni in su).

Ribomunyl va utilizzato soltanto su prescrizione medica.

Quando non si può usare Ribomunyl?

Ribomunyl non deve essere utilizzato in caso d’ipersensibilità al principio attivo o a una delle

sostanze ausiliarie secondo composizione.

Ribomunyl non deve essere assunto da persone che soffrono di malattie autoimmuni.

Quando è richiesta prudenza nella somministrazione di Ribomunyl?

Qualora in seguito all’assunzione di Ribomunyl comparisse febbre alta (sopra i 39 °C), interrompere

il trattamento e consultare quanto prima un medico.

Se si dovessero manifestare reazioni d’ipersensibilità al medicamento, interrompere il trattamento.

Sono stati riferiti attacchi di asma in soggetti asmatici che assumevano medicamenti contenenti

principi attivi simili a quelli di Ribomunyl. In caso di un attacco di asma, il trattamento va interrotto

e non deve essere ripetuto.

Ribomunyl non deve essere assunto da persone che soffrono di infezione intestinale acuta.

Ribomunyl Granulato non va somministrato ai bambini sotto i 2 anni. Le compresse di Ribomunyl

non sono indicate per i bambini sotto i 6 anni.

Le compresse di Ribomunyl contengono sorbitolo e pertanto non devono essere assunte in caso di

intolleranza al fruttosio.

Informi il suo medico o il suo farmacista nel caso in cui

·soffre di altre malattie,

·soffre di allergie o

·assume o applica esternamente altri medicamenti (anche se acquistati di sua iniziativa!).

Si può somministrare Ribomunyl durante la gravidanza o l'allattamento?

Non essendo disponibili dati sull’uso di Ribomunyl durante la gravidanza e l’allattamento, si

sconsiglia alle donne in stato di gravidanza e in allattamento di assumere il medicamento.

Consultare un medico o un farmacista prima di assumere questo medicamento.

Come usare Ribomunyl?

Ribomunyl viene assunto per via orale.

Nel primo mese: assumere 1 compressa o il contenuto di 1 bustina il mattino a digiuno per 4 giorni

consecutivi alla settimana, per 3 settimane.

2°-6° mese: assumere 1 compressa o il contenuto di 1 bustina il mattino a digiuno per 4 giorni

consecutivi, una volta al mese.

Inghiottire le compresse con poca acqua. Sciogliere il contenuto della bustina in mezzo bicchiere

d’acqua e bere subito.

Bambini

Le compresse sono indicate unicamente per i bambini di età superiore ai 6 anni. Il granulato può

essere somministrato ai bambini a partire da 2 anni.

Se ha assunto più Ribomunyl di quanto dovrebbe, si rivolga al suo medico.

Se ha dimenticato di assumere Ribomunyl, non prenda una dose doppia per compensare la dose

dimenticata.

Non modifichi di propria iniziativa la posologia prescritta. Se ritiene che l’azione del medicamento

sia troppo debole o troppo forte ne parli al suo medico o al suo farmacista.

Quali effetti collaterali può avere Ribomunyl?

Si possono manifestare i seguenti effetti collaterali:

È necessario interrompere l’uso di Ribomunyl e informare immediatamente il medico se compare

febbre superiore a 39 °C; questo effetto indesiderato si manifesta occasionalmente (può interessare

fino a 1 persona su 100).

Effetti collaterali frequenti (possono interessare fino a 1 persona su 10) riferiti:

–malattie da raffreddamento, otiti (infezioni alle orecchie) e tonsilliti (infiammazioni delle tonsille).

Effetti collaterali occasionali (possono interessare fino a 1 persona su 100) manifestatesi:

–sinusite (infiammazione dei seni paranasali) e bronchite (infiammazione dei bronchi), tosse;

–aumento della secrezione salivare all’inizio del trattamento;

–linfonodi ingrossati;

–disturbi gastrointestinali quali nausea, vomito, diarrea, dolori addominali, infezione

gastrointestinale; infiammazione gastrointestinale;

–stanchezza.

Non è possibile stimare la frequenza dei seguenti effetti indesiderati in base ai dati disponibili:

–reazioni allergiche (eruzione cutanea, difficoltà respiratorie, orticaria);

–gravi reazioni allergiche che provocano gonfiore al viso o alla gola;

–asma;

–piccole macchie cutanee di colore rosso-violaceo causate da sanguinamenti e noduli sotto pelle;

–eczema, arrossamento della pelle;

–laringite.

Se osserva effetti collaterali qui non descritti dovrebbe informare il suo medico o il suo farmacista.

Di che altro occorre tener conto?

Conservare a temperatura ambiente (15-25 °C).

Il medicamento non dev’essere utilizzato oltre la data indicata con ”EXP” sul contenitore.

Il medico o il farmacista, che sono in possesso di un’informazione professionale dettagliata, possono

darle ulteriori informazioni.

Cosa contiene Ribomunyl?

1 compressa o 1 bustina di Ribomunyl contiene RNA ribosomiale liofilizzato, dosato a 0,525 mg:

· Frazioni ribosomiali: 10 parti di cui

- Klebsiella pneumoniae 3,5 parti

- Streptococcus pneumoniae 3 parti

- Streptococcus pyogenes 3 parti

- Haemophilus influenzae 0,5 parti

· Frazioni di membrana: 15 parti di cui

- Klebsiella pneumoniae 15 parti.

Sostanze ausiliarie

Compressa: sorbitolo, magnesio stearato e silice colloidale anidra

Granulato in bustina: D-mannitolo e povidone

Numero dell’omologazione

00570, 00587 (Swissmedic)

Dove è ottenibile Ribomunyl? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica.

Confezioni da 12 compresse e 12 bustine (granulato).

Titolare dell’omologazione

Pierre Fabre Pharma AG, 4123 Allschwil

Questo foglietto illustrativo è stato controllato l’ultima volta nel novembre 2014 dall’autorità

competente in materia di medicamenti (Swissmedic).

17-1-2019

Outcome of the public consultation on the draft statement on genotoxicity assessment of chemical mixtures

Outcome of the public consultation on the draft statement on genotoxicity assessment of chemical mixtures

Published on: Wed, 16 Jan 2019 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the genotoxicity assessment of chemical mixtures. The draft statement was prepared by a dedicated working group of the Scientific Committee and endorsed by the Scientific Committee for public consultation at its 89th plenary meeting of 28‐29 May 2018. The public consultation for this document was open from 26 June until 9 ...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Voorstelling van Zaken “GOED SCHEIDEN” in Internationaal Theater Amsterdam

Voorstelling van Zaken “GOED SCHEIDEN” in Internationaal Theater Amsterdam

De komende Voorstelling van Zaken GOED SCHEIDEN vindt plaats op dinsdag 26 februari 2019 van 14.00-17.15 uur in Internationaal Theater Amsterdam (voorheen Stadsschouwburg Amsterdam). De voorstelling is bedoeld voor professionals betrokken bij scheidingen. Phaedra Werkhoven, journalist en ervaringsdeskundige, leidt de gesprekken op het toneel. Acteurs Gijs Scholten van Aschat, Jacob Derwig en Hannah van Lunteren spelen scènes die de scheidingsproblematiek op unieke wijze zullen laten zien. Scheiden is pij...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

3-1-2019

Results RNA LLC Issues Voluntary Worldwide/Nationwide Recall of Lubrisine Eye Drops Due to Manufacturing Sterility Concerns and Undeclared Colloidal Silver

Results RNA LLC Issues Voluntary Worldwide/Nationwide Recall of Lubrisine Eye Drops Due to Manufacturing Sterility Concerns and Undeclared Colloidal Silver

Results RNA LLC is voluntarily recalling Lubrisine Eye Drops to the healthcare practitioner, retail or consumer level. This product, in a recent FDA inspection, was found to be manufactured using practices that do not support its sterility and contained undeclared colloidal silver.

FDA - U.S. Food and Drug Administration

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft guidance on the scientific requirements for health claims related to muscle function and physical performance, prepared by the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), supported by the Working Group on Claims. The draft guidance was endorsed by the Panel for public consultation ...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Pending EC decision:  Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Pending EC decision: Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

11-9-2018

Livestock Health and Food Chain Risk Assessment

Livestock Health and Food Chain Risk Assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EUFORA fellowship programme ‘Livestock Health and Food Chain Risk Assessment’ was proposed by the Animal and Plant Health Agency (APHA), a British governmental institution responsible for safeguarding animal and plant health in the UK. The working programme, which was organised into four different modules, covered a wide range of aspects related to risk assessment including identification of emerging risks, risk prioritisation methods, scanning surveilla...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Update of the tolerable upper intake level for vitamin D for infants

Update of the tolerable upper intake level for vitamin D for infants

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the draft Scientific Opinion on the update of the tolerable upper intake level for vitamin D for infants. This draft Scientific Opinion was prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) and endorsed by the Panel for public consultation by written procedure on 9 April 20...

Europe - EFSA - European Food Safety Authority Publications

10-8-2018

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

FDA - U.S. Food and Drug Administration

30-5-2018

Procleix West Nile Virus (WNV) Assay

Procleix West Nile Virus (WNV) Assay

Product approval information is indicated for the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.

FDA - U.S. Food and Drug Administration

8-5-2018

New Tariff for fees collected by the Icelandic
Medicines Agency

New Tariff for fees collected by the Icelandic Medicines Agency

Tariff No 404/2018 for marketing authorisations, annual fees and other licence fees for medicinal products and other related products, collected by the Icelandic Medicines Agency, was published in the Official Journal on 25th of april 2018 and came into force on the 7th of May 2018.TARIFF No 545/2017 for inspections and registration regarding medical devices remains the same. 

IMA - Icelandic Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: In vitro transcribed patient-specific mRNA molecule encoding neo-epitopes that are specifically derived from tumour tissue

Scientific recommendation on classification of advanced therapy medicinal products: In vitro transcribed patient-specific mRNA molecule encoding neo-epitopes that are specifically derived from tumour tissue

Scientific recommendation on classification of advanced therapy medicinal products: In vitro transcribed patient-specific mRNA molecule encoding neo-epitopes that are specifically derived from tumour tissue

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Four in vitro transcribed mRNA molecules each encoding one tumour antigen

Scientific recommendation on classification of advanced therapy medicinal products: Four in vitro transcribed mRNA molecules each encoding one tumour antigen

Scientific recommendation on classification of advanced therapy medicinal products: Four in vitro transcribed mRNA molecules each encoding one tumour antigen

Europe - EMA - European Medicines Agency

5-12-2018

Luxturna (Spark Therapeutics Ireland Ltd)

Luxturna (Spark Therapeutics Ireland Ltd)

Luxturna (Active substance: voretigene neparvovec) - Centralised - Authorisation - Commission Decision (2018)7970 of Wed, 05 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4451

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Active substance: Synthetic antisense oligonucleotide directed against human dystrophin pre-mRNA) - Orphan designation - Commission Decision (2018)5283 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/032/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2041 (Ionis USA Limited)

EU/3/18/2041 (Ionis USA Limited)

EU/3/18/2041 (Active substance: 2'-O-(2-methoxyethyl) antisense oligonucleotide targeting microtubule-associated protein tau pre-mRNA) - Orphan designation - Commission Decision (2018)5273 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/050/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)5284 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/052/18

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2033 (Real Regulatory Limited)

EU/3/18/2033 (Real Regulatory Limited)

EU/3/18/2033 (Active substance: Codon-optimised human ornithine transcarbamylase mRNA complexed with lipid-based nanoparticles) - Orphan designation - Commission Decision (2018)4178 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/022/18

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2026 (Alnylam UK Limited)

EU/3/18/2026 (Alnylam UK Limited)

EU/3/18/2026 (Active substance: Synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)3394 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/18

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2025 (Pharma Gateway AB)

EU/3/18/2025 (Pharma Gateway AB)

EU/3/18/2025 (Active substance: Modified mRNA encoding human methylmalonyl-coenzyme A mutase encapsulated into lipid nanoparticles) - Orphan designation - Commission Decision (2018)3393 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/017/18

Europe -DG Health and Food Safety

29-5-2018

EU/3/15/1453 (Roche Registration GmbH)

EU/3/15/1453 (Roche Registration GmbH)

EU/3/15/1453 (Active substance: Chimeric 2'-O-(2-methoxyethyl) modified oligonucleotide targeted to huntingtin RNA) - Transfer of orphan designation - Commission Decision (2018)3401 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/256/14/T/01

Europe -DG Health and Food Safety

29-5-2018

EU/3/11/857 (Alnylam Netherlands B.V.)

EU/3/11/857 (Alnylam Netherlands B.V.)

EU/3/11/857 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against transthyretin mRNA) - Transfer of orphan designation - Commission Decision (2018)3398 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/142/10/T/02

Europe -DG Health and Food Safety

18-5-2018

EU/3/16/1684 (Pharma Gateway AB)

EU/3/16/1684 (Pharma Gateway AB)

EU/3/16/1684 (Active substance: Modified mRNA encoding the UGT1A1 protein) - Transfer of orphan designation - Commission Decision (2018)3132 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/047/16/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3148 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/041/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3147 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/039/14/T/01

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (Active substance: Adeno-associated viral vector serotype 9 encoding miRNA against human superoxide dismutase 1) - Orphan designation - Commission Decision (2018)2404 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/254/17

Europe -DG Health and Food Safety